Rinvoq
Authorised
This medicine is authorised for use in the European Union
upadacitinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Rinvoq is a medicine that acts on the immune system (the body’s natural defences) and is used to treat:
- adults with moderate to severe rheumatoid arthritis (a disease that causes inflammation of the joints) that cannot be controlled well enough with disease-modifying anti-rheumatic medicines (DMARDs) or if the patient cannot take these medicines. It can be used on its own or with methotrexate, another medicine that acts on the immune system;
- adults with active psoriatic arthritis (inflammation of the joints associated with psoriasis, a disease causing red, scaly patches on the skin) that cannot be controlled well enough with DMARDs, or if the patient cannot take these medicines. Rinvoq can be used on its own or with methotrexate;
- adults with active axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis, when an X-ray shows the disease, and non-radiographic axial spondyloarthritis, when there are clear signs of inflammation but an X-ray does not show disease. It is used when other treatments do not work well enough;
- adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen;
- adults and children from 12 years of age with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry) who can be treated with a medicine given by mouth or by injection;
- adults with ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) or Crohn’s disease (an inflammatory disease affecting the gut). Rinvoq is used to treat moderately to severely active disease when other medicines, including biological medicines, do not or no longer work, or if the patient cannot take them.
Rinvoq contains the active substance upadacitinib.
Rinvoq can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in diagnosing and treating the conditions for which the medicine is used.
Rinvoq is available as tablets to be taken by mouth once a day. The dose depends on the disease Rinvoq is used for and other factors including the patient’s age and the severity of the disease.
The doctor may interrupt treatment in case of certain side effects, including falls in blood cell counts. Treatment may also be stopped if the patient does not respond after a number of weeks, depending on the condition Rinvoq is used for.
For more information about using Rinvoq, see the package leaflet or contact your healthcare provider.
In patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, atopic dermatitis, ulcerative colitis and Crohn’s disease, the immune system attacks healthy tissue, causing inflammation, pain and other symptoms.
Upadacitinib, the active substance in Rinvoq, is an immunosuppressant. This means that it reduces the activity of the immune system. Upadacitinib works by blocking the action of enzymes called Janus kinases, which are involved in processes that lead to inflammation. Blocking the effect of Janus kinases helps to control the symptoms of the conditions.
Rheumatoid arthritis
Five studies involving a total of nearly 4,400 patients found Rinvoq was effective in reducing symptoms in patients with moderate to severe rheumatoid arthritis. These studies involved rating disease activity in 28 joints in the body on a standard scale. They showed that Rinvoq was effective at clearing the symptoms or achieving low disease activity in 43 to 48% of patients; this compared with a reduced disease activity in 14 to 19% of patients given placebo (a dummy treatment) or methotrexate.
Psoriatic arthritis
Two studies, involving over 2,000 patients with active psoriatic arthritis despite prior treatment, showed that Rinvoq, used on its own or with methotrexate, was more effective than adalimumab (another medicine used for psoriatic arthritis) or placebo at reducing the symptoms of the disease. Between 57 and 71% of patients on Rinvoq achieved a reduction in symptoms after 12 weeks of treatment, compared with 65% of patients treated with adalimumab and 24 to 36% of patients given placebo.
Axial spondyloarthritis
For ankylosing spondylitis a 14-week study involving 187 patients whose disease could not be controlled well enough with other treatments showed that Rinvoq was effective at reducing symptoms of the disease. Of the patients who received Rinvoq, around 52% had a reduction in the number and severity of symptoms, compared with 26% of patients given placebo.
In addition, a study involving around 300 patients with non-radiographic axial spondyloarthritis whose diseases could not be controlled well enough with other treatments showed that Rinvoq improved symptoms of the disease: symptoms improved by at least 40% after 14 weeks in 45% of patients taking Rinvoq compared with 23% of patients given placebo.
Giant cell arteritis
A main study involving 428 adults with giant cell arteritis found that Rinvoq was more effective than placebo at reducing symptoms of the disease. All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months. One year after starting treatment, 46% of patients treated with Rinvoq did not have symptoms of giant cell arteritis compared with 29% patients receiving placebo.
Atopic dermatitis
Rinvoq was effective at clearing up the skin and reducing disease extent and severity in patients with moderate to severe atopic dermatitis in three main studies involving a total of 2,584 adults and children from 12 years of age. The studies compared the effects of two doses of Rinvoq (15 and 30 mg a day), used with or without corticosteroids applied to the skin, with placebo.
Treatment with Rinvoq on its own reduced the extent and severity of the disease in 60 to 70% of patients taking the 15 mg dose and in 73 to 80% of those taking 30 mg, compared with 13 to 16% of patients given placebo. Clear or almost clear skin was achieved in 39 to 62% of patients taking Rinvoq, compared with 5 to 8% of patients given placebo.
Similar results were observed when Rinvoq was used with corticosteroids: the extent and severity of the disease were reduced in 65 to 77% of patients taking Rinvoq compared with 26% of patients given placebo; skin cleared or almost cleared in 40 to 59% of patients taking Rinvoq, compared with 11% of patients given placebo.
Ulcerative colitis
Two main studies involving 988 patients showed that Rinvoq was effective at clearing symptoms and improving the inflammation in the lining of the bowel of patients with moderately to severely active ulcerative colitis whose disease had not responded to other treatment or who could not tolerate other treatment. In the study patients took Rinvoq 45 mg or placebo once a day. After eight weeks of treatment, the proportion of patients on Rinvoq whose symptoms were gone or almost gone, along with normal or mild inflammation in the lining of the bowel, was 26% in the first study and 34% in the second study, compared with almost 5% and 4% for those given placebo.
In a third study, a total of 451 patients from the first two studies whose ulcerative colitis condition had improved with Rinvoq went on to receive 15 or 30 mg of the medicine once daily, or placebo. After 52 weeks of treatment, symptoms of ulcerative colitis were gone or almost gone in 42% of patients on 15 mg Rinvoq and in 52% of patients on 30 mg Rinvoq, compared with around 12% of patients on placebo.
Crohn’s disease
Two main studies involving a total of 1,021 patients with moderately to severely active Crohn’s disease showed that Rinvoq was effective at improving symptoms of the disease. After 12 weeks of treatment during which patients took Rinvoq 45 mg or placebo once a day, the proportion of patients on Rinvoq whose symptoms were gone or almost gone in the two studies was 40% and 51%, compared with 14% and 22% for those taking placebo. Inflammation of the gut lining was reduced by more than half in 35% and 46% of patients given Rinvoq, compared with 4% and 13% in patients given placebo.
A third study involved 502 patients from the first two studies whose Crohn’s disease had improved with Rinvoq. Patients took 15 or 30 mg of the medicine once daily, or placebo. After 52 weeks of treatment, symptoms of Crohn’s disease were gone or almost gone in 36% of patients given 15 mg Rinvoq and in 46% of patients given 30 mg Rinvoq, compared with 14% of patients given placebo. Inflammation of the gut lining was reduced by more than half in 28% and 40% of patients given Rinvoq 15 mg and 30 mg, respectively, compared with 7% of patients given placebo.
For the complete list of side effects and restrictions with Rinvoq, see the package leaflet.
The most common side effects with Rinvoq seen in people with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis (which may affect more than 2 in 100 people) include upper respiratory tract (nose and throat) infections, increased blood levels of the enzymes creatine phosphokinase (CPK, an enzyme released into the blood when a muscle is damaged), alanine transaminase or aspartate transaminase (indicating possible liver damage), bronchitis (inflammation of the airways in the lungs), nausea (feeling sick), cough and hypercholesterolaemia (high blood cholesterol levels).
In people with atopic dermatitis, the most common side effects (which may affect more than 2 in 100 people) include upper respiratory tract infection, acne, herpes simplex (a viral infection that causes cold sores), headache, increased blood levels of CPK, cough, folliculitis (inflammation of hair follicles), abdominal (belly) pain, nausea, neutropenia (low levels of neutrophils, a type of white blood cell), fever and influenza (flu).
In people with ulcerative colitis and Crohn’s disease, the most common side effects (which may affect more than 3 in 100 people) include upper respiratory tract infection, fever, increased blood levels of CPK, anaemia (low levels of red blood cells), headache, acne, herpes zoster (a painful, blistering rash in one part of the body), neutropenia, rash, pneumonia, hypercholesterolaemia, bronchitis, tiredness, increased levels of liver enzymes, folliculitis, herpes simplex, and influenza.
In people with giant cell arteritis, the side effects were similar to those seen for other conditions, in addition to peripheral oedema (swelling of the arms and legs, which may affect up to 1 in 10 people) and a higher frequency of headache (which may affect more than 1 in 10 people).
The most common serious side effect is serious infections.
Rinvoq must not be used in patients with tuberculosis or serious infections. It must also not be used in patients with severe liver problems or during pregnancy.
Rinvoq should only be used if no suitable treatment alternatives are available in patients aged 65 years or above, in patients with a history of cardiovascular disease (such as heart attack or stroke) or with risk factors for such a disease (such as current or previous long-term smokers), or in patients at increased risk of cancer.
Rinvoq was effective at controlling moderate to severe rheumatoid arthritis, as well as psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis and Crohn’s disease in patients whose disease had not improved enough with, or could not take, other treatments. Studies found that it reduced disease activity when used alone or when combined with other medicines, depending on the condition treated. It was also found to be effective at treating giant cell arteritis in adults. Patients treated with Rinvoq may have side effects that include infection, neutropenia, and blood tests that suggest liver or muscle damage and raised blood lipids (fats). However, these side effects are considered manageable.
The European Medicines Agency therefore decided that Rinvoq’s benefits are greater than its risks and that it can be authorised for use in the EU.
The company that markets Rinvoq will provide educational materials to healthcare professionals and patients with information about the risks with the medicine, particularly the risk of serious infections, blood clots, major cardiovascular events, cancer or gastrointestinal perforation in certain patients. They will also include a reminder that Rinvoq should not be taken during pregnancy and that women taking Rinvoq must use contraception (birth control) during and, four weeks after stopping, treatment.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rinvoq have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rinvoq are continuously monitored. Side effects reported with Rinvoq are carefully evaluated and any necessary action taken to protect patients.
Rinvoq received a marketing authorisation valid throughout the EU on 16 December 2019.
Product information
Latest procedure affecting product information:
II/0056
04/04/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Rinvoq
- Active substance
- upadacitinib
- International non-proprietary name (INN) or common name
- upadacitinib
- Therapeutic area (MeSH)
- Arthritis, Rheumatoid
- Anatomical therapeutic chemical (ATC) code
- L04AA44
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Giant cell arteritis
RINVOQ is indicated for the treatment of giant cell arteritis in adult patients.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn’s disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
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